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Abstract:

The invention relates to a device for treating an individual suffering
from cardiac or circulatory arrest or from a stroke, comprising blood
withdrawal means (BE) that can be applied to the individual (P), an
analysis unit (BA) directly or indirectly connected to the blood
withdrawal means for detecting and providing, in the form of a blood
analysis result (BAE), at least one characteristic of the blood, directly
or indirectly connected to a return means (BR) that can be applied to the
individual (P) and is designed to deliver a substance to the individual
via the return means (BR).

Claims:

1-26. (canceled)

27. A device for treating an individual suffering from cardiac or
circulatory arrest or from a stroke, comprising blood withdrawal means
for application to the individual, an analysis unit directly or
indirectly connected to the blood withdrawal means for detecting and
providing a blood analysis result including at least one characteristic
of the blood, directly or indirectly connected to a return means for
application to the individual for delivering a substance to the
individual via the return means; and an operative unit comprising at
least one reservoir in which at least two substances are stored, a dosage
unit combined with the at least one reservoir which, in response to the
blood analysis result, selects from the at least two substances at least
one substance or produces a mixture of at least two of the substances so
that at least one selected substance or the mixture can be introduced
into the individual directly or indirectly via the return means.

28. A device in accordance with claim 27, wherein: the blood withdrawal
means is within a blood flow path to the return means; the analysis unit,
the at least one reservoir unit and dosage unit are within the blood flow
path; and before delivery to the individual via the return means, the at
least one selected substance or the mixture can be blended with the blood
taken from the individual in order to obtain modified blood.

29. A device in accordance with claim 28, wherein: at least one conveying
means is within the blood flow path to provide regulated flow.

30. A device in accordance with claim 27, wherein: the analysis unit
comprises a plurality of sensors each for recording at least one blood
parameter.

31. A device in accordance with claim 28, wherein: the analysis unit
comprises a plurality of sensors each for recording at least one blood
parameter.

32. A device in accordance with claim 29, wherein: the analysis unit
comprises a plurality of sensors each for recording at least one blood
parameter.

34. A device in accordance with claim 27, wherein: the at least one
reservoir stores a plurality of substances which are present in solid,
liquid or gaseous form, are stored in separate reservoir chambers, and
are supplied in dosed form either individually or in combination by the
dosage unit.

35. A device in accordance with claim 28, wherein: the at least one
reservoir stores a plurality of substances which are present in solid,
liquid or gaseous form, are stored in separate reservoir chambers, and
are supplied in dosed form either individually or in combination by the
dosage unit.

36. A device in accordance with claim 29, wherein: the at least one
reservoir stores a plurality of substances which are present in solid,
liquid or gaseous form, are stored in separate reservoir chambers, and
are supplied in dosed form either individually or in combination by the
dosage unit.

37. A device in accordance with claim 35, wherein: the at least one
reservoir stores a plurality of substances which are present in solid,
liquid or gaseous form, are stored in separate reservoir chambers, and
are supplied in dosed form either individually or in combination by the
dosage unit.

38. A device in accordance with claim 34, wherein: the dosage unit
includes at least one mixing container which via a controllable dosing
means is connected to individual reservoir chambers, and the at least one
mixing container is directly or indirectly connected to the return means
through a further controllable dosing means.

46. A device in accordance with claim 27, comprising: an evaluation and
control unit for exchanging data with the analysis unit and the dosage
unit in response to a result of the blood analysis generates control
signals for controlling the dosage unit.

47. A device in accordance with claim 46, comprising: a monitoring unit
including at least one measuring means for determining at least one
parameter of the individual, the at least one parameter being selected
from a group of physiological parameters of the individual comprising
mean arterial pressure, central nervous pressure, pulmonary artery
pressure, oxygen saturation and blood temperature; whereby the monitoring
unit is connected to the evaluation and control unit to provide at least
a unilateral data exchange.

48. A device in accordance with claim 27, wherein: the analysis unit
comprises a sensor for recording at least one property of the blood of
the individual.

49. A device in accordance with claim 48, wherein: the sensor unit is
directly or indirectly connected to the blood withdrawal means.

51. A device in accordance with claim 46, wherein: the analysis unit, the
operative unit and the evaluation and control unit are portable.

52. A device in accordance with claim 28, comprising: a by-pass line
within the blood flow path between the blood withdrawal means and the
return means, a by-pass line directly upstream of the return means
through which some of the modified blood returned to the individual may
be supplied to the analysis unit, and in response to a comparison by the
analysis unit, the dosage unit changes a quantity of the at least one
substance supplied into the blood path flow for at least one determinable
blood parameter.

53. A device in accordance with claim 27, comprising: a heat exchanger
directly or indirectly connected to the return means.

54. A device in accordance with claim 53, wherein the evaluation and
control unit generates control signals which are transmitted to the
conveying means and to the heat exchanger so that the pressure, flow rate
and temperature of the at least one substance to be introduced into the
individual are selectable.

55. A device in accordance with claim 28, comprising: an oxygen
enrichment and depletion unit for the blood disposed within the blood
flow path between the blood withdrawal means and the return means.

56. A method of treating an individual suffering from cardiac arrest or
stroke from which blood is taken which is analyzed in a blood analyzer, a
result of the blood analysis being performed by the blood analyzer and at
least one evaluation criterion and from at least two stored substances a
type and quantity of at least one substance or a substance mixture is
determined, comprising: a) adding in dosed form to the blood taken from
the individual the at least one substance or the substance mixture which
is reperfused into the individual as a perfusion solution to replace the
removed blood to obtain modified blood which is reperfused into the
individual or b) the at least one substance or the substance mixture is
reperfused into the individual as a perfusion solution in place of the
removed blood.

57. A method in accordance with claim 56, comprising: as part of the
blood analysis, at least one determined blood parameter is compared with
a nominal value and in an event of a quantitatively predeterminable
deviation from the nominal value, one substance which influences the
blood parameter is selected and added to the removed blood or the
perfusion solution in a quantity dependent on the quantitative deviation.

58. A method in accordance with claim 56, wherein: some of the modified
blood is removed to have a repeated blood analysis; and if the at least
one determined blood parameter deviates from the nominal value, a
correction to a type and/or quantity of the at least one added substance
is performed.

59. A method in accordance with claim 56, wherein: blood withdrawal,
blood analysis, adding the at least one substance to the patient's blood
or the perfusion solution, as well as the reperfusion of the modified
blood or perfusion solution are performed in situ.

60. A method in accordance with claim 56, wherein: in addition to the
blood analysis, at least one physiological parameter of the individual is
determined, and in response to both the blood analysis result and the at
least one physiological parameter of the individual, a type and quantity
of the at least one substance to be added to the removed blood or
perfusion solution, and pressure, flow rate and temperature of a modified
blood flow or solution to be reperfused into the individual, are
selected.

61. A method in accordance with claim 56, wherein: the reperfusion of the
modified blood or the perfusion solution into the patient performed at
least two different areas of the body with different reperfusion
parameters in terms of pressure, flow rate, temperature and/or perfusion
duration.

62. A method in accordance with claim 20, wherein: blood is taken at a
controlled flow rate of at least 1 l/min.

63. A method in accordance with claim 62, wherein: the controlled flow
rate is 6 to 8 l/min.

Description:

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The invention relates to a device for treating an individual
suffering from cardiac insufficiency, cardiac arrest, circulatory arrest
or stroke.

[0003] 2. Description of the Prior Art

[0004] Given the current level of knowledge and the current therapeutic
methods, individuals, more particularly patients, who have suffered
cardiac arrest, can only be resuscitated without damage to the brain or
the heart functions if cardiopulmonary resuscitation is successfully
carried out within a period of three to five minutes after the cardiac
arrest has occurred. Resuscitation carried out with a further time delay
inevitably leads to severe cerebral damage due to reperfusion with normal
blood which causes massive damage to the ischaemic tissue.

[0005] Ischaemic and reperfusion modifications in tissues mainly play a
central role in heart surgery. For example mycocardial ischaemia is
either induced by the surgeon himself, for instance as part of global
ischaemia through aortic clamping, or also during a heart transplant
and/or regionally in "off-pump surgery" for application of a coronary
by-pass. However, emergency operations are also performed on patients
with myocardial ischaemia who, for example, are suffering from
cardiogenic shock, acute coronary occlusion or a condition immediately
after resuscitation. For these reasons heart surgeons have been
intensively occupied with ischaemia and reperfusion phenomena for
decades.

[0006] In accordance with current knowledge, it can be assumed that
ischaemia, even long-lasting ischaemia, only causes relatively small
structural damage to the heart muscle. However, if after such an
ischaemic attack the myocardium is reperfused with normal blood under
"physiological" conditions, an additional damaging mechanism occurs
explosively, which in the meantime has been well researched as
"reperfusion damage". On reperfusion of an ischaemically damaged
myocardium with normal blood, processes suddenly occur which can
definitively destroy the already damaged tissue.

[0007] To prevent or completely hinder the reperfusion damage occurring
through reperfusion with normal blood, concepts have been developed which
after revascularization initially endeavour to treat the ischaemically
damaged myocardium, whereby both the composition of the initial
reperfusate and the conditions of the initial perfusion are aimed at
treating the damage occurring during the ischaemia and/or ruling out
possibly occurring reperfusion damage right from the start.

[0008] The concept of controlled reperfusion is based on the one hand on
modifying the initial reperfusate differently from the body's own blood
as well as modifying the conditions of the initial reperfusion.

[0009] In connection with this, DE 696 31 046 T2 discloses a device for
treating a patient with cardiac arrest which uses the known method of
selective aortic arch perfusion, SAAP in short, in which in order to
carry out relatively isolated perfusion of the heart and brain, a balloon
occlusion catheter is applied, usually via the patient's femoral artery,
to the location of the descending aortic arch and then dilated, after
which an oxygenated blood substitute solution, for example
perfluorocarbon emulsion or a polymerized haemoglobin solution is then
infused via the lumen of the SAAP catheter. The blood substitute
solution, also known as a protective solution, is administered
intracorporeally using a pulsing device with a pulsating rhythm. In a
variant embodiment the known device has a blood withdrawal means, with
which blood can be withdrawn from the patient which is taken to blood
oxygenation means for oxygenation and, together with a protective
solution added to the oxygenated blood, is infused into the patient via
blood return means. It should be noted here that to carry out selective
aortic arch perfusion and thus to use the above device, a surgical
procedure and the associated clinical infrastructure are necessary.

[0010] U.S. Pat. No. 5,195,942 discloses a comparable procedure for
resuscitating a person, in which by inflating a balloon catheter in the
region of the ascending aorta in order to increase the blood flow into
the coronary arteries, a blood-compatible, oxygen liquid is injected for
flowing on into the coronary arteries.

[0011] U.S. Pat. No. 7,387,798 B2 describes a method for the resuscitation
of patients suffering from cardiac arrest, in which a liquor fluid is
taken from the subarachnoid area of the patient's central nervous system.
An artificially composed cerebrospinal fluid containing a large number of
components, such as sodium, potassium, calcium, magnesium, water,
polypeptides, insulin and ATP, is then infused, whereupon conventional
cardiopulmonary resuscitation is carried out

[0012] For resuscitating a patient or an animal, U.S. Pat. No. 5,416,078
discloses administering a solution of Deferoxamine with water-soluble
biopolymers to the patient to be treated.

[0013] WO 94/21195 describes administering an A3 adenosine receptor
agonist for preparing the organ in order to protect it against ischaemic
damage.

[0014] In EP 1 021 084 B1 a method of eliminating or reducing ischaemic
damage to an organ is set out. Here, the damaged organ is rinsed with a
buffered physiological solution in order to remove acidic products which
have accumulated in the organ during the period of oxygen deficiency.

[0015] U.S. Published Application 2005/0101907 A1 describes an automatic
system for the resuscitation of a patient in which a single fluid is
infused in relation to the fluid inflow as function of physiological
parameters of the patient.

[0016] A comparable automatic infusion system for treating trauma patients
is disclosed in U.S. Pat. No. 5,938,636, for infusion of an administered
fluid into the patient with the infusion pressure and infusion flow being
sensor-recorded and computer-monitored.

[0017] DE 10 2008 024 471 A1 describes a heart-lung by-pass device which
can be connected to a patient by one tube to the arterial and one tube to
the venous blood vessel system. Extracorporeally, between the tubes,
there is a blood flow line along which bi-directionally operating pumps
and a fluid reservoir can be provided. Controllable fluid control valves
fitted with sensors are also arranged along the blood flow line. Through
bi-directional pump operation, the lungs assume the function of the
oxygenators of the heart-lung by-pass device.

[0018] U.S. Pat. No. 5,308,320 describes a portable resuscitation device
for cardiac arrest patients having blood withdrawal means, a pump for
moving the blood within the devices, means for oxygenating the blood and
means for returning the oxygen-enriched blood back into the blood
circulation.

SUMMARY OF THE INVENTION

[0019] The invention is a device for providing full resuscitation of a
patient without the risk of ischaemic damage during a period of time
between the onset of the cardiac arrest and the initiation of
resuscitation measures which is considerably greater than the previous
critical time window of 3 to 5 minutes. The device allows as fully
automatic resuscitation as possible so that no complicated therapeutic
precautions have to be taken in situ. The device also is lightweight and
portable and independently operable as possible so that it can be used as
an instrument for emergency medicine on site. The device is useful for a
cardiac arrest, and for cardiac insufficiency or a stroke, based on the
same principles.

[0020] The invention exerts, by way of at least one sensor-supported blood
analysis of the individual's blood, an individual blood
analysis-dependent influence on the blood taken from the individual so
that an individually selected substance or an individually produced
substance mixture is added or mixed to the blood taken from the
individual to obtain "modified blood." The thus obtained "modified blood"
is reperfused into the individual as a reperfusate with the goal of
partially or fully preventing the ischaemic tissue damage otherwise
occurring on activation of the natural or artificially-supported blood
circulation system or on initial blood supply to areas of tissue
disconnected from the natural blood circulation for a shorter or longer
period.

[0021] The device in accordance with the invention for treating an
individual with cardiac arrest or stroke, includes blood withdrawal means
attachable to the individual for withdrawing at least part of the blood
from an individual, an analysis unit directly or indirectly connected to
the blood withdrawal means for recording and providing at least one
property of the blood in the form of blood analysis result, an operative
unit, which is indirectly or directly connected to return means
attachable to the individual and designed to administer a substance to
the individual via the return means. The operative unit has at least one
reservoir in which at least two substances are stored. The reservoir unit
is combined with a dosage unit, which, taking into consideration a blood
analysis result determined by the analysis unit, selects at least one of
the two substances or prepares a mixtures of at least two of the
substance. The at least one selected substance or the mixture can then be
applied to the individual directly or indirectly via the return means.

[0022] The individual is, more particularly, a human or animal patient.
The terms "patient" and "individual" are used synonymously here. Cardiac
insufficiency is understood, for example, as a traumatic or pathological
reduction in the output of the heart, which may be caused by a heart
attack, cardiogenic shock or heart failure.

[0023] In one variant, the device of the invention also has a sensor
device, recording at least one property of the individual's blood, which
generates a sensor signal, which is then evaluated by the analysis unit
and made available as a blood analysis. The analysis unit is
fundamentally suitable for working with the sensor unit so that a sensor
signal determined/generated by the sensor unit can be transmitted from
the sensor unit to the analysis unit. The device can be produced with
already known sensors.

[0024] The sensor unit can comprise a plurality of sensors, of which each
sensor records at least one parameter or property of the blood.

[0025] In one variant, the sensor unit is designed as a non-invasive
component which can be directly or indirectly attached to the individual.

[0026] The withdrawal means for taking the blood are envisaged and set up
to withdraw at least part of the blood from an individual before the
blood is influenced by the operative unit. For this the withdrawal means
are, for example, invasively attachable to the individual. In this way at
least two litres, more particularly at least three litres, more
particularly at least four litres, more particularly all the blood in the
individual's blood vessels, can be withdrawn.

[0027] Through the also provided return means, the withdrawn and treated
or influenced blood, that is the "modified blood," can be returned into
the body of the individual. The return means can also be invasively
attached to the individual.

[0028] On the one hand, at least one substance in the form of an additive
to the blood in the patient, for example, can be administered by way of
an injection into the infusion, or the patient's blood is removed from
the patient by way of withdrawal means and extracorporeally enriched or
treated with the at least one substance which is then reperfused into the
patient in the form of "modified blood." It is also conceivable to remove
essentially all the blood from a patient and, instead of this blood, to
return the "modified blood" or a solution, individually adapted to the
patient and containing at least one substance, directly to the patient in
order to then be able to initiate the process of resuscitation without
tissue damage.

[0029] In one embodiment, the sensor unit is directly or directly
connected to the withdrawal means.

[0030] For the purpose of modification and/or manipulation of the
patient's own blood individually adapted to the patient situation, in one
variant the operative unit is controlled or regulated by an evaluation
and control unit on the basis of the analysis result which represents the
patient's current condition.

[0031] Advantageously, the analysis unit, the operative unit and the
evaluation and control unit are designed as a portable and standard unit,
in which the sensor unit is preferably part of the standard unit.

[0032] The sensor unit generates the sensor signal which represents the at
least one property of the blood taken from the patient and can be
transmitted by cable or wirelessly to the analysis unit, whereby on the
basis of the analysis results, the evaluation and control unit generates
control or regulating signals. These can be used, for example, to select
or dose the type and/or quantity the substance or substance mixture to be
added. Here, the sensor unit records at least one of the following
parameters: pH value, partial oxygen pressure (pO2), partial carbon
dioxide pressure (pCO2), potassium content (K), sodium content (Na),
calcium content (Ca), base excess (BE), lactate value (La) and glucose
content (Gu).

[0033] The device in accordance with the invention is preferably also
designed as a portable and easy to operate, more particularly as a fully
autonomous unit, so that it is not necessarily exclusively usable by
medical specialist personnel. One form of embodiment comprises a portable
handy unit, from which only two tubes extend, which on the patient side
are connected to the blood vessel system. One tube is for taking the
blood from the patient, via which the patient's blood automatically flows
out into the unit, in which an analysis of the blood and corresponding
modification of the blood take place. The appropriately "modified blood"
is then reperfused into the patient via the other tube. Alternatively,
this device also makes it possible, before the "modified blood" is
returned to the patient, to administer to the patient an individually
composed perfusion solution, the composition of which depends on the
result of the analysis of the patient's own blood. For a successful
treatment outcome, it is therefore conceivable in a first step to largely
substitute the blood with an individually composed perfusion solution.
Only later on during the treatment is the aforementioned "modified blood"
administered, possibly after successfully carrying out further
resuscitation measures.

[0034] In one variant the operative unit is intended and designed to
dispense the at least one substance to the individual or the blood in
dosed form at the correct temperature and/or pressure.

[0035] Preferably, a monitoring unit is provided which has at least one
measuring means for recording the at least one parameter of the
individual, which is selected from the group of physiological parameters
of the individual, comprising mean arterial pressure, central nervous
pressure, pulmonary arterial pressure, oxygen saturation and blood
temperature, whereby the monitoring unit is connected to an evaluation
and monitoring device for at least unilateral data exchange.

[0036] Fundamentally, the blood is taken from the patient as a bodily
fluid. However, the embodiments of the device relating to blood as the
bodily fluid can also be used for other bodily fluids in an analogous
manner.

[0037] The blood withdrawal means to be applied to the patient is
preferably connected via a blood flow path, in the simplest case in the
form of a hollow tube, to the blood return means applicable to the
patient, whereby, more particularly, along the blood flow path the
reservoir unit of the operative unit is provided, which contains at least
two substances, and from which at least one of the substances to be
selected or a substance mixture can be added to the blood flow path or
the return means.

[0038] Along the blood flow path a heat exchanger unit can also be
provided which is directly or indirectly connected to the return means.
At least one conveying means integrated along the blood flow path is also
for adjusting the blood flow along the blood flow path in order to assure
simple transporting of the blood from the individual's body and of the
modified blood into the individual's body. Preferably, for returning the
blood to the body a further, separate conveying means is provided, with
which flow characteristics can be set which are individual and above all
independent in terms of pulsability, flow pressure and speed.

[0039] For controlling all present conveying means as well as the heat
exchanger unit, the evaluation and control unit generates further
signals, so that ultimately the flow pressure, the flow rate and/or
temperature of the at least one substance or the "modified blood" to be
returned to the patient can be set in a predetermined manner.

[0040] The analysis unit with its sensor unit is also arranged along the
blood flow path, so that in terms of individual blood parameters, more
particularly a large number of blood parameters, the blood can be
analyzed and a blood analysis result made available for further
evaluation. The analysis preferably takes place online, that is on site,
while the blood is being taken from the patient by the blood withdrawal
means.

[0041] Taking into consideration the blood analysis result determined by
the analysis unit, the dosage unit connected to the reservoir unit brings
a predeterminable quantity of the at least one substance from the
reservoir unit and adds it into the blood flow path or the return means.
This means that with the aid of the dosage unit an individually composed
reperfusate based on the current condition of the patient to be treated
is produced, which is then reperfused into the patient via the applied
blood return means.

[0042] Particularly in the reperfusion of "modified blood" into the
patient, but also in the simple administration of a perfusion fluid, the
addition of at least one, more particularly many substances to the
patient's own blood or the perfusion solution as well as the perfusion
itself, takes place, with regard to the selection of the reperfusion
pressure, the flow rate, the reperfusion duration and the temperature of
the reperfusate, taking in consideration and adapted to the patient's
current sensor-recorded blood picture. The aforementioned monitor unit
can be used for this for example. In this way the selection and setting
of the physiological reperfusion conditions can also take place taking
into consideration the physiological parameters determined by the
monitoring unit.

[0043] The aforementioned evaluation and control unit, which can, for
example, be connected both to the analysis unit and to the dosage unit
for the purpose of at least unilateral data exchange, is used to evaluate
blood analysis results determined by the analysis unit and to determine
the type and quantity of the substances to be added to the patient's own
blood or the perfusion solution. The blood analysis result is evaluated
in the evaluation and control unit under predetermined evaluation
criteria, which can also take the physiological patient parameters
recorded by the monitoring unit into consideration.

[0044] Data transmission connections in the form of conventional data
transmission cables or wireless technologies are used for the at least
unilateral exchange of data.

[0045] As a result of the evaluation of the blood analysis result, the
evaluation and control unit generates control signals which are
transmitted to the dosage unit for selecting the type and quantity of the
substances to be added to the blood flow. In connection with this, the
term "dosage unit" is understood as a technical means with which it is
possible, from a number of substances stored in separate reservoir
chambers, on the basis of defined mixing plan in which the selection of
the relevant substances and the quantity of the substance to be added is
defined, to make a mixture which is ultimately to be added to the
patient's own blood. It is not necessary to premix the selected
substances before adding them to the patient's own blood as the separate,
dosable addition of individually selected substances to the blood flow
path is also conceivable.

[0046] Preferably. the dosage unit has at least one mixing container,
which has individually controllable dosing means which are connected to
the individual reservoir chambers. In the mixing container, a substance
mixture to be added to the bodily fluid of the individual is produced in
the mixing container in the form of a solution, a suspension or an
emulsion. Thus, the substances stored in the reservoir chambers are not
necessarily fluid and an individual substance can also be present in
solid or powder form or also in the gaseous phase. For example, the
following substances or substance classes from which an individual
selection can be made to produce a substance mixture to be added to the
bodily fluid of the individual can be stored in the individual reservoir
chambers: alkaline or acidic buffer solution, substances affecting the
sodium, potassium and/or calcium content, blood-thinning substances, free
radical trapping agents, glutamate, aspartame, heart-rhythm-stabilizing
substances (Lidocaine), substances influencing the leukocyte count,
osmotically-active substances, namely salts, glucoses, proteins.

[0047] In one variant, a filter unit for blood filtering is provided along
a blood flow path between the blood withdrawal means and the return
means. This filter may include a leukocyte filter for example.

[0048] In one variant along the blood flow path between the blood
withdrawal means and the return means, directly upstream of the return
means a by-pass line is provided, through which some of the "modified
blood" to be returned to the individual can be supplied to the analysis
unit and in the event of an anomalous nominal/actual comparison, the
dosage unit changes the quantity of the at least one substance supplied
into the blood path flow for at least one determinable blood parameter.

[0049] In one variant, the individual components of the device are so
compact and light in weight that the device is portable.

[0050] In one variant, along a blood flow path between the blood
withdrawal means and the return means, an oxygenation and
oxygen-depletion unit for the blood is provided in order to match the
oxygen content of the modified blood to be returned to the relevant
requirements.

[0051] One form of embodiment of the device in accordance with the
invention includes a portable base module, hereinafter referred to as
GIRD (as acronym for Controlled Integrated Resuscitation Device. The CIRD
base module has an extracorporeal blood flow path which can be applied by
way of suitable blood withdrawal and (blood) return means to the
patient's blood circulation, more particularly in the area of the femoral
artery and femoral vein. Along the extracorporeal blood flow path, the
CIRD base module has a conveying means for maintaining the blood flow, an
oxygenator for enriching the blood with oxygen, as well as a device for
CO2 depletion and finally, a leukocyte filter, and can be modularly
expanded with the aforementioned blood analysis unit as well as the
previously described reservoir and dosing unit.

[0052] With the aid of such a device, for the automatic operation and
control of which the also previously mentioned evaluation and control
unit is provided, mostly in the form of a computer unit, it is possible
to quickly and automatically analyze the blood taken from a patient
suffering from cardiac arrest and to determine exactly which composition
of additional substances has to be added to the patient's own blood. From
the result of the blood analysis, and, possibly, also taking into account
the sensor-recorded physiological parameters of the patient, a
reperfusate is finally automatically produced which is individually
adapted to the patient and introduced into the patient under optimized
conditions in terms of pulsability, flow pressure, flow rate and/or
temperature. This creates ideal conditions for the initial perfusion in
terms of the reperfusion pressure, the reperfusion flow and the
reperfusion duration.

[0053] As the device in accordance with the invention allows continuous
monitoring of the patient's own blood, the reperfusion conditions and the
composition of the reperfusate can be adapted in situ or online, that is
continuously, to the current condition of the patient being reperfused.
More particularly, through the in situ/online measurement of certain
blood parameters, such as the concentration of potassium ions, lactate,
glucose or the pH value etc. as well as through the combined measurement
of haemodynamic parameters by way of suitable monitoring sensors which
record the flow resistance, temperature, the flow rate as well as the
flow pressure etc. within the blood flow path, automatic adjustments can
be made as part of the controlled whole-body reperfusion.

[0054] The device in accordance with the invention for extracorporeal
whole-body reperfusion was successfully tested in experiments on pigs.
Fifteen minutes after controlled induced cardiac arrest in normothermic
conditions, animals could be successfully resuscitated without noticeable
or measurable organ damage or neurological damage. These experiments
show, for the first time. that it is possible to achieve fully functional
neurological recovery, even 15 minutes after the onset of cardiac arrest,
a fact which is in sharp contrast to the model and limitations of current
conventional treatments. More particularly, through the lightweight and
portable design of the device in accordance with the invention,
completely new perspectives are opened up for emergency medicine which
could result in very many patients, who today have no chance of
resuscitation and/or full recovery, not only being able to be saved in
future, but also to recover without neurological damage.

[0055] The subject matter of the invention is also a method of treating an
individual suffering from cardiac arrest or stroke in which blood is
taken from the individual which then undergoes a blood analysis, whereby
taking into consideration a blood analysis result determined by the
analysis unit and at least one evaluation criterion, from at least two
stored substances the type and quantity of at least one of the substances
or a substance mixture are determined, which in dosed form is added to
the removed blood to obtain "modified blood" which is reperfused into the
individual or which is reperfused into the individual in the form of
perfusion solution in place of the removed blood.

[0056] In one variant of the method of the invention, the blood is taken
from the individual before recording the properties and returned after
adding the at least one selected substance to the blood.

[0057] In one variant, the recording, evaluation and influencing take
place in a closed control cycle.

[0058] In one variant of the method of the invention, the analysis result
is compared with a nominal value, and in the event of a quantitatively
predeterminable deviation from the nominal value, a substance influencing
the blood property forming the basis of the analysis result is selected
and introduced into the individual or the blood in a quantity depending
on the quantitative deviation.

[0059] In one variant of the method of the invention, at least two litres,
more particularly at least three litres, more particularly at least four
litres, more particularly all the blood in the individual's blood
vessels, is to be withdrawn before reperfusion of the modified blood
takes place.

[0060] In one variant of the method of the invention, the blood is taken
from the patient over a period of 10 seconds to 3 minutes, more
particularly 20 seconds to 2 minutes, more particularly 30 seconds to 1
minute.

[0061] In one variant of the method of the invention, some of the
"modified blood" is branched off for the purpose of repeated blood
analysis, and if the at least one determined blood parameter deviates
from the nominal value, a correction to the type and/or quantity of the
at least one added substance takes place.

[0062] In one variant of the method of the invention, the procedures of
taking the blood, blood analysis, adding the at least one substance to
the blood or perfusion solution as well as the reperfusion of the
modified blood or perfusion solution take place in situ.

[0063] In one variant of the method, in addition to the blood analysis, at
least one physiological parameter of the individual is determined. Taking
into consideration both the blood analysis result and also the at least
one physiological parameter of the individual, the type and quantity of
the at least one substance to be added to the removed blood or perfusion
solution, as well as the pressure, flow rate and temperature of a
modified blood flow or solution to be reperfused into the individual, are
selected.

[0064] In one variant of the method of the invention, the reperfusion of
the "modified blood" or perfusion solution into the individual takes
place at least two different parts of the body each with different
reperfusion parameters in terms of pressure, flow rate, temperature
and/or reperfusion duration.

[0065] In one variant of the method of the invention, the blood is taken
at a controlled flow rate of at least 1 l/min, more particularly from 6
to 8 l/min.

[0066] All the above-mentioned method variants can be combined with each
other in any way and order.

BRIEF DESCRIPTION OF THE INVENTION

[0067] The invention is described below, without restricting the general
concept of the invention, by way of examples of embodiments with
reference to the drawings, in which

[0068] FIG. 1 shows a block diagram of an illustration of the individual
components of an example of embodiment;

[0072] In FIG. 1, a block diagram for illustrating all the components of a
form of embodiment of a device in accordance with the invention is shown.
The use of the device is explained in more detail using the example of a
human patient P as an individual who has suffered a cardiac arrest.
Applied to the patient P in the area of femoral vein in order take blood
are blood withdrawal means BE, from which a blood flow path BL extends
extracorporeally, which passes through various technical components and
from which at various points lines branch off and into which at various
points lines open, which are discussed in more detail below. Finally the
blood flow path BL enters the patient again, more particularly in the
area of the femoral artery to which a blood returns means BR are also
applied.

[0073] For controlled blood withdrawal from the patient P and for setting
the reperfusion parameters under which the device to be described returns
"modified blood" or reperfusate into the patient's blood circulation, a
conveying means LF is provided along the blood flow path BL, which is
more particularly in the form of a centrifugal pump and is to be seen as
a component of the lightweight and portable CIRD. The conveying means LF
can also be variably adjusted in terms of conveying output, conveying
characteristics and duration, that is pressure, duration and pulsability,
via an evaluation and control unit A/S yet to be described in more
detail. In addition, the portable CIRD has an oxygenator O, with which
the blood taken from the patient is enriched with oxygen. In certain
cases, with the aid of the oxygenator, it is also possible to deplete
oxygen from the patient's own blood. There is also a gas blender G, which
influences the blood CO2 content, usually in the form of depletion
of the CO2 content in the patient's own blood. For individual
temperature control of the blood flow within the blood flow path BL, the
oxygenator O is also connected to a heat exchanger unit. The heat
exchanging characteristics are influenced in a controlled manner by the
evaluation and control unit A/S. Finally, the portable CIRD unit
comprises a leukocyte filter through which the leukocyte content of the
patient's blood can be influenced.

[0074] A first by-pass lien A1 is provided in the blood flow path BL
directly leaving the patient, via which some of the patient's blood is
branched off into an analysis unit BA in which the patient's blood is
analyzed by sensors with respect to various blood parameters.

[0075] In an expanded form of embodiment, the device of FIG. 1 may be
supplemented with further functional units, which are able to modify or
manipulate the patient's blood in the following manner.

[0076] Means are thus provided for influencing the patient's blood through
extracorporeal pressure exertion on the patient in such a way that in
terms of time and space the pressure exertion takes place in a
predeterminable manner on the patient evenly or selectively. Such means
for the mechanical influencing of the patient's blood can alternatively
also be applied invasively and for intracorporeal pressure exertion on
the patient's blood.

[0077] In addition, means for the thermal influencing of the patient's
blood for extracorporeal temperature control can be provided and designed
so that in terms of time and space, the temperature control takes place
in a predeterminable manner on the patient evenly or selectively. Such
means for the thermal influencing of the patient's blood can
alternatively also be applied invasively and for intracorporeal
temperature control of the patient's blood so that in terms of space and
time the temperature control takes place in a predeterminable manner
within the patient evenly or selectively.

[0078] Preferably, to return the blood to the body of the patient P, along
the blood flow path, before or after the leukocyte filter LF at least one
further, separate conveying means (not shown) can be provided, with which
conveying characteristics can be set which are individual and above all
independent in relation to pulsability, flow pressure and speed.

[0079] In FIG. 2, an analysis unit BA is shown schematically for more
detailed explanation. It is assumed that via line A1, part of the
patient's blood will reach the blood analyzing analysis unit BA. Within
the analysis unit BA, more particularly in the form of a sensor unit, a
number of individual sensors SE1 to SEn are provided, which
analyze the blood with regard to various blood parameters. Advantageously
brought together in the analysis/sensor unit are known sensors each one
of which is able to record at least one of the following non-exhaustively
listed parameters: pH-value, partial oxygen pressure (pO2), partial
carbon dioxide pressure (pCO2), potassium content (K), sodium
content (NA), calcium content (Ca), the base deviation designated as BE,
also known as base excess/base deficit with which metabolic disorders of
the acid-base balance can be detected, lactate value (La), glucose
content (Gu) to name but a few.

[0080] Each individual sensor SE1 . . . n determines one blood
parameter SEE1 . . . n, characteristic of the patient's blood, which
together produce the so-called blood analysis result BAE which reflects
the current quality of the patient's own blood. More particularly, the
blood analysis result is transmitted via a data transmission cable to the
evaluation and control unit A/S in which the blood analysis result BAE
undergoes separate analysis and evaluation based on medical evaluation
criteria.

[0081] The purpose of the device in accordance with the invention is
ultimately to transform, through the addition of certain substances, the
patient's blood into a modified state which can be characterized in the
fact that the specially "modified blood" or the reperfusate should not
cause any tissue damage during initial reperfusion into the patient for
the purpose of the patient's resuscitation. In addition, it intended to
reduce/heal ischaemic damage which may have already occurred in certain
tissue areas.

[0082] Within the evaluation and control unit A/S the current
sensor-recorded individual blood parameters SEE1 . . . n of the
patient's blood are compared with blood parameter-specific references or
nominal values, which are to be restored through modification of the
patient's blood. In accordance with such an evaluation the type and
quantity of the relevant substances to be added to the patient's blood
are determined. The evaluation/control unit is in informal communication
with a reservoir unit R as well as a dosage unit D combined therewith,
which are both shown schematically in FIG. 3. In accordance with FIG. 3
the reservoir unit R comprises four individual reservoir chambers in
which four different substances S1, S2, S3 and S4 are
stored. More such reservoir chambers can of course be provided, that is
in general reservoir chambers for storing n different substances. The
individual reservoirs are each connected to a mixing container MB,
whereby along the connection lines dosage means in the form of stop
valves V1, V2, V3 and V4 are provided. Depending on
the current blood analysis result BAE and the additive requirement
determined by the evaluation/control unit for the substance to be mixed
to the patient's blood, the evaluation/control unit generates control
signals Si1, Si2, Si3, Si4 for operating the dosage
means V1 to V4. Finally, the mixture of the individual
substance prepared in the mixing container MB is introduced into the
blood flow path BL.

[0083] In a variant a monitoring unit M, see FIG. 1, is provided, which
via sensors applied to the patient P, records physiological patient
parameters, for example the mean arterial pressure, the central venous
pressure, the pulmonary arterial pressure, oxygen saturation, as well as
body temperature, to name but a few. The physiological patent parameters
are also transmitted by the monitoring unit M to the evaluation and
control unit A/S, where after being taken into consideration the
evaluation and control unit generates the control signals for the dosage
unit.

[0084] Before the reperfusate is returned to the patient P via the blood
flow path BL, with the aid of the analysis unit BA, an analysis of the
"modified blood"/reperfusate is carried out to ensure that a correctly
composed/modified reperfusate is being returned to the patient. For this,
a second by-pass line A2 is provided immediately upstream of the blood
return means BR which diverts some of the "modified blood"/reperfusate
into the analysis unit BA. In the analysis unit BA, repeat sensor
recording of the individual blood parameters SEE1 . . . n takes
place, which undergo a nominal/actual comparison in the evaluation and
control unit A/S. If deviations occur, the generated control signals
Si1, Si2, Si3, Si4 are corrected in order influence
the dosage means V1 to V4.

[0085] Furthermore, on the basis of the blood analysis results BAE and the
physiological patient parameters determined by the monitoring unit M, the
evaluation and control unit generates control signals to control the
conveying means LF determining the flow characteristics within the blood
flow path BL, as well as the heat exchanger WT determining the
temperature level of the reperfusate being infused into the patient,
ultimately with the aim of tissue-protecting reperfusion of the "modified
blood" back into the patient's blood circulation. In doing so, the
parameters of the flow pressure, the flow rate, the pulsability, flow
duration and temperature of the repefusate are individually matched to
the patient.

[0086]FIG. 4 shows a schematic blood diagram of a further embodiment of
the invention. Sensor unit SEH, provides information obtained from the
bodily fluid, more particularly blood, of a patient P. The sensor signals
generated by the sensor unit SEH are forwarded to an analysis unit A
which generates an analysis result representing the current state of the
bodily fluid/blood. Based on at least one evaluation criterion, for
example, the analysis result is evaluated by an evaluation and control
unit A/S. The evaluation and control unit then generates control or
regulating signs for the controlled activation of an operative unit KE
which influences the bodily fluid and, in particular, can be composed of
at least one of the following sub-units: means for adding at least one
substance to the bodily fluid MS, means of mechanically influencing the
bodily fluid MM and means of thermally influencing the bodily fluid. Each
of these means can be combined with joint means. Depending on the means
that can be activated by the evaluation and control unit A/S, the bodily
fluid of the patient P undergoes therapeutic manipulation or modification
for the purpose of preventing ischaemic tissue damage.

[0087] The device in accordance with the invention is particularly compact
and, if possible, designed in a single housing to assure as simple and
fully automatic operation as possible. The processes of taking the blood,
blood analysis, addition of at least one substance to the patient's blood
to obtain "modified blood," and the reperfusion of the "modified blood"
take place automatically and in situ, without further knowledge about the
person to be resuscitated having to be available. The device obtains all
information for successful reperfusion from the described sensor data
sensors in the form of data from the automatic blood screening and
sensor-detectable physiological data.

[0088] With the benefit of the device in accordance with the invention,
controlled whole-body reperfusion can be carried out with which the
duration of ischaemia, until irreversible damage to individual organs or
even the entire body, can be considerably increased compared with the
current narrow time limits.